ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,— 510(k) K991455

Name: FDA 510(k) clearance K991455
Creator: U.S. Food and Drug Administration
Published: 1999-06-25

Substantially Equivalent

Trophy Radiologie

FDA 510(k) clearance K991455 for ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,, Substantially Equivalent on 1999-06-25. Applicant: Trophy Radiologie. Device class: 2.

Clearance details

Applicant: Trophy Radiologie
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1999-04-26
Decision date: 1999-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marne La Vallee Cedex 2, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.